*CDRH Center Tracking System (CTS) Modernization
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $3,000,000 to $7,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CDRH Acquisition Liaison cdhracquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is modernizing the CDRH Center Tracking System (CTS), a mission-critical enterprise platform supporting the full Total Product Life Cycle regulatory review activities across the Center, with estimated solicitation release on July 1, 2026, and estimated award on January 1, 2027. The modernization will replace aging infrastructure carrying two decades of technical debt—including thousands of embedded business rules—that currently constrains performance, scalability, and architectural stability, and will deliver a more performant, scalable, maintainable, and interoperable regulatory platform to reduce operational risk and support CDRH's regulatory mission across evolving program demands.
The estimated award value ranges from $3 million to $7 million. No set-aside applies to this procurement. Questions and inquiries should be directed to the FDA's CDRH Acquisitions mailbox at cdhracquisitions@fda.hhs.gov.
Forecast text
The CDRH Center Tracking System (CTS) is a mission-critical, enterprise-wide platform that supports nearly all Total Product Life Cycle (TPLC) regulatory review activities across the Center; however, more than two decades of accumulated technical debt - including thousands of embedded business rules - have created significant performance constraints, scalability limitations, and architectural fragility that increasingly threaten CDRH's regulatory efficiency and capacity to respond to evolving program demands. The modernization will deliver a more performant, scalable, maintainable, and interoperable regulatory platform, reducing operational risk and enabling CDRH to more effectively support its regulatory mission across the full product life cycle. This investment directly advances CDRH's priority of Regulatory Efficiency & Modernization and aligns with the FDA Strategic Priority of Innovation and Global Leadership by replacing aging infrastructure with a modern, adaptable architecture capable of meeting current and future mission needs.
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